A phase III study of tri-modality combination therapy with induction docetaxel plus cisplatin and 5-fluorouracil (DCF) vs definitive chemoradiotherapy for locally advanced unresectable squamous cell carcinoma of the thoracic esophagus(JCOG1510,TRIANgLE)
- Conditions
- locally advanced unresectable squamous cell carcinoma of the thoracic esophagus
- Registration Number
- JPRN-UMIN000031165
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 230
Not provided
1) Synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers. 2) Prior surgery for head and neck superficial carcinoma within 5 years. 3) Diagnosed with active infectious disease requiring systemic treatment by imaging or bacteriological inspections, and body temperature >= 38 degrees Celsius. 4) Positive for HBs antigen or HIV antigen. 5) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding. Male subjects who want pregnancy of their partner. 6) Psychological disorder difficult to participate in this clinical study. 7) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 8) Under treatment by flucytosine, phenytoin, or warfarin potassium . 9) Previous histry of allergy to iodine. 10) Diabetes mellitus uncontrollable with continuous use of insuline or hypoglycemic agents. 11) Severe emphysema or pulmonary fibrosis based on chest CT. 12) Uncontrolled arterial hypertension. 13) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. 14) Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method progression free survival, complete response proportion of chemoradiotherapy, response proportion of DCF (in case of Arm B), adverse events of DCF and chemoradiotherapy, late onset adverse events, perioperative complications (both Arm A and Arm B)